上海义森生物有限公司:格列吡嗪杂质A
2012
The eTACT project, the EDQMs’ anti-counterfeiting traceability service for medicines was launched. Ukraine became the first country to ratify the Medicrime Convention and the 38th Member of the European Pharmacopoeia Convention and the Republic of Guinea and Singapore received observer status. The ISO 9001:2008 certificate was extended to cover the management of the elaboration, revision, correction and suppression of European Pharmacopoeia texts, their publication in printed and electronic format, as well as their distribution.
2011On 24 June 2011, The EDQM signed a trilateral Memorandum of Understanding (MoU) with the State Administration of Traditional Chinese Medicine of the People's Republic of China (SATCM) and its National Key Institute of TCM Quality Control (NKI-TCM).
The ISO 9001:2008 certificate was extended to the market surveillance of finished medicinal products and issuance of guidelines for the release of human immunological and blood derivative medicinal products.
2010
Memorandums of Understanding are signed with the National Institute of Food and Drug Safety Evaluation (NIFDS), Korea Food and Drug Administration, and the Chinese National Institute of Food and Drug Control (NIFDC), respectively.
The EDQM takes over responsibility for the establishment, preparation, storage and distribution of WHO International Chemical Reference Substances (ICRS).
上海义森生物有限公司:格列吡嗪杂质A
英国政府化学家实验室(Laboratory of the Government Chemist, LGC)成立于1842年,迄今已有近170年的历史。自1870年以来,LGC即为法定的英国政府化学实验室,是食品安全领域政府和业界纠纷案件的法定仲裁者。LGC标准品公司是LGC有限公司重要组成部分,也是欧洲zui综合全面的标准物质提供者。LGC医药杂质标准品不仅可用于药物成分及剂型中杂质的鉴别与控制,为药物的申报与审批过程提供详实可靠的数据,同时也用于分析方法的建立与验证,紧密地参与例行的质控管理过程。
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